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Otsuka Pharmaceutical Co., Ltd. v. Mylan Inc.

United States District Court, D. New Jersey

March 23, 2015

OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff,
v.
MYLAN INC., MYLAN PHARMACEUTICALS INC., and MYLAN LABORATORIES LIMITED, Defendants.

Melissa A. Chuderewicz, Esq., PEPPER HAMILTON LLP, Princeton, N.J., and James B. Monroe, Esq. Paul W. Browning, Esq., Denise Main, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, D.C., Attorneys for Plaintiff.

Arnold B. Calmann, Esq., Jeffrey Soos, Esq., Katherine A. Escanlar, Esq., SAIBER LLC, Newark, N.J. and Deepro R. Mukerjee, Esq., Lance A. Soderstrom, Esq., James C. Grant, Esq., Jonathan D. Parente, Esq., ALSTON & BIRD LLP, New York, N.Y., Attorneys for Defendant.

OPINION

JEROME B. SIMANDLE, Chief District Judge.

I. INTRODUCTION

This patent infringement action is one of twenty-four related actions concerning various defendants' submission of abbreviated new drug applications (hereinafter, "ANDAs") for Food and Drug Administration (hereinafter, "FDA") approval to market generic versions of Plaintiff Otsuka Pharmaceutical Co., Ltd.'s (hereinafter, "Otsuka") aripiprazole product known as Abilify®. Defendants Mylan Inc., Mylan Pharmaceuticals Inc. ("Mylan Pharma") and Mylan Laboratories Limited ("Mylan Labs" and collectively, "Mylan") move to dismiss Otsuka's Complaint for lack of personal jurisdiction.[1] [Docket Item 15.]

Mylan Inc., "one of the world's leading generic and specialty companies, " and its subsidiaries, Mylan Pharma and Mylan Labs, specifically argue that Mylan lacks any claim-related or jurisdiction-conferring contacts to New Jersey. (See, e.g., Mylan's Reply at 1-10.) Otsuka counters, however, that Mylan's substantial connections with this forum readily enable this Court to exercise personal jurisdiction over each Mylan entity. (See, e.g., Otsuka's Opp'n at 9-19.) Otsuka, in particular, argues that Mylan's compliance with the State of New Jersey's foreign corporation licensing and registration statute constitutes consent to this Court's jurisdiction; that Mylan's future intent to market and distribute its generic products in New Jersey suffices for purposes of specific jurisdiction; and that Mylan's compliance with licensing and/or registration requirements, revenue generation, and related activities otherwise constitute "continuous and systematic" contacts with this forum for purposes of general jurisdiction. (See, e.g., id.)[2]

Mylan does not dispute that each of its entities complies with the statutory registration requirements of the State of New Jersey, that each of its entities holds a wholesale distribution license in the State of New Jersey, nor that each of its entities generate revenue attributable to sales in the State of New Jersey. (See Tighe Dec. at ¶¶ 8, 9, 11; Tighe Supplemental Dec. at ¶ 2.) Rather, Mylan disputes whether this quantum of connections suffices for purposes of personal jurisdiction, given the Supreme Court's "sea-change" jurisdictional decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), and because Mylan maintains no corporate offices, facilities, nor records in this State. (See, e.g., Mylan's Br. at 5-11; Mylan's Reply at 1-10.)

The primary issues before the Court are whether the record demonstrates that the Mylan Defendants' contacts with this forum render them "at home" in the State of New Jersey; whether Mylan's registration to do business in New Jersey and appointment of an in-state agent for service of process amount to consent to this Court's jurisdiction; and whether, in submitting an ANDA for FDA approval, the Mylan Defendants purposefully directed activities at this forum.

For the reasons that follow, the Court finds that this Court may exercise general jurisdiction over Mylan Inc. and Mylan Pharma. Because Mylan Labs, however, lacks sufficient jurisdictional contacts with this forum, Mylan Labs will be dismissed. Mylan's motion will, accordingly, be denied with respect to Mylan Inc. and Mylan Pharma, but granted with respect to Mylan Labs.

II. BACKGROUND

A. Otsuka and New Drug Application No. 21-436

Otsuka, a pharmaceutical company organized and existing under the laws of Japan, holds New Drug Application (hereinafter, "NDA") No. 21-436, approved by the FDA, for aripiprazole tablets, which Otsuka markets under the trademark Abilify®. (See Compl. at ¶¶ 1, 16-17.)

In connection with Abilify's® listing in the Orange Book, the FDA's book of drug products approved under the Food, Drug, and Cosmetic Act (hereinafter, the "Orange Book"), 21 U.S.C. § 355(j), Otsuka identifies the following patents: U.S. Patent Nos. 8, 017, 615 ("the '615 patent"), 8, 580, 796 ("the '796 patent"), 8, 642, 760 ("the '760 patent"), 7, 053, 092 ("the '092 patent") and 8, 642, 600 ("the '600 patent"), all of which Otsuka owns by virtue of assignment. (See id. at ¶¶ 5, 13, 17, 27, 30, 37, 40, 47, 50, 57, and 60.)

B. Mylan Inc., Mylan Pharma, and Mylan Labs

As stated above, the pending motion concerns the jurisdictional contacts of three Mylan entities: Mylan Inc. and its two subsidiaries, Mylan Pharma and Mylan Labs.

Mylan Inc., a Pennsylvania corporation having a principal place of business in Canonsburg, Pennsylvania, manufactures, markets, imports, and sells generic and specialty pharmaceutical products throughout the United States, including in New Jersey. (See id. at ¶ 2, 7; Tighe Dec. at ¶¶ 2-3, 11.) Indeed, Mylan Inc. expressly identifies itself as "one of the world's leading generic and specialty pharmaceutical companies, " which "markets more than 1, 300 different products in around 140 different countries and territories" (Tighe Dec. at ¶ 3), and "holds the number one ranking in the U.S. generics prescription market in terms of sales and the number two ranking in terms of prescriptions dispensed." (Compl. at ¶ 7; see also Ex. A to Otsuka's Opp'n.)

In 2006, the State of New Jersey authorized Mylan Inc. to "transact business" as a "foreign profit corporation" pursuant to N.J.S.A. §§ 14A:13-4, 14-1, -2. (See Ex. F to Otsuka's Opp'n.) In connection with New Jersey's authorization, Mylan Inc. identified its registered office and designated an in-state agent for service process of process. (See Tighe Dec. at ¶ 8 (noting Mylan Inc.'s compliance with statutory registration requirements); Ex. F to Otsuka's Opp'n (identifying an agent in West Trenton, New Jersey).) In addition to being registered in New Jersey, Mylan holds a wholesale distribution license, and generates annual revenues in excess of $100 million in this State. (See Tighe Dec. at ¶ 11.) Finally, Mylan Inc. has actively litigated, as both plaintiff and defendant, over 30 cases in this District. (See Ex. K to Otsuka's Opp'n (summarizing the cases).) Nevertheless, Mylan Inc. maintains no permanent, physical presence in the State of New Jersey.

Mylan Inc.'s subsidiary, Mylan Pharma serves as Mylan Inc.'s "primary U.S. pharmaceutical research, development, manufacturing, marketing and distribution subsidiary." (Tighe Dec. at ¶ 4; Ex. A to Otsuka's Opp'n; Compl. at ¶ 8.) Like its corporate parent, however, Mylan Pharma "does not have any manufacturing plants, corporate offices, facilities, or other real property in New Jersey." (Tighe Dec. at ¶ 6.) Rather, Mylan Pharma exists and operates in the State of West Virginia. (See generally id.) Nevertheless, Mylan Pharma has registered to do business in New Jersey and has appointed an in-state agent for service of process. (See Ex. G to Otsuka's Opp'n.) In addition, Mylan Pharma holds a wholesale distribution license in New Jersey, and generates annual revenues in excess of $50 million in this State. (Tighe Dec. at ¶¶ 9, 11; Tighe Supplementary Dec. at ¶ 2.) Finally, Mylan Pharma has been an equally active litigant in this District, having litigated over 30 cases, as both plaintiff and defendant. (See Ex. K to Otsuka's Opp'n (summarizing the cases).)

Mylan Labs, Mylan Inc.'s Indian subsidiary, constitutes "one of the world's largest manufacturers of active pharmaceutical ingredients (APIs)'" (Compl. at ¶ 9 (citation omitted)), and manufactures and supplies "low cost, high qualify API for [Mylan Inc.'s] own products and pipeline." (Ex. A to Otsuka's Opp'n.) Unlike its parent and sister corporations, however, Mylan Labs has not registered as a foreign corporation in New Jersey, nor appointed an agent for service of process. (See Tighe Dec. at ¶ 8.) Mylan Labs does, however, hold a wholesale distribution license in New Jersey, generates revenues "attributable to ...


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